form10q.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, DC
20549
FORM
10-Q
(Mark
one)
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended March 31, 2008
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from____________ to ____________.
Commission
File Number: 0-19961
ORTHOFIX
INTERNATIONAL N.V.
(Exact
name of registrant as specified in its charter)
Netherlands Antilles
|
|
N/A
|
(State
or other jurisdiction of incorporation
or organization)
|
|
(I.R.S.
Employer Identification No.)
|
|
|
|
7
Abraham de Veerstraat
|
|
|
Curaçao
|
|
|
Netherlands Antilles
|
|
N/A
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
|
599-9-4658525
|
|
|
(Registrant’s
telephone number, including area code)
|
|
Indicate
by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes x No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
Accelerated filer x Accelerated
filer o
Non-Accelerated filer o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
As
of May 2,
2008, 17,088,856 shares of common stock were issued and
outstanding.
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3
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Item
1.
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3
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Item
2.
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18
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Item
3.
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25
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Item
4.
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26
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27
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Item
1.
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27
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Item
1A.
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29
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Item
6.
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29
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33
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Forward-Looking
Statements
This Form
10-Q contains forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, which relate to our business and financial
outlook and which are based on our current beliefs, assumptions, expectations,
estimates, forecasts and projections. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,”
“intends,” “predicts,” “potential” or “continue” or other comparable
terminology. These forward-looking statements are not guarantees of
our future performance and involve risks, uncertainties, estimates and
assumptions that are difficult to predict. Therefore, our actual
outcomes and results may differ materially from those expressed in these
forward-looking statements. You should not place undue reliance on
any of these forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and we undertake no
obligation to update any such statement to reflect new information, the
occurrence of future events or circumstances or otherwise.
Factors
that could cause actual results to differ materially from those indicated by the
forward-looking statements or that could contribute to such differences include,
but are not limited to, unanticipated expenditures, changing relationships with
customers, suppliers and strategic partners, unfavorable results in litigation
matters, risks relating to the protection of intellectual property, changes to
the reimbursement policies of third parties, changes to governmental regulation
of medical devices, the impact of competitive products, changes to the
competitive environment, the acceptance of new products in the market,
conditions of the orthopedic industry and the economy, currency or interest rate
fluctuations and the other risks described under Item 1A – “Business – Risk
Factors” in our Annual Report on Form 10-K for the fiscal year ended December
31, 2007 and Part II, Item 1A – “Risk Factors” in this Form
10-Q.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
Dollars, in thousands except share data)
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
Assets
|
|
(Unaudited)
|
|
|
(Note
2)
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
26,731 |
|
|
$ |
25,064 |
|
Restricted
cash
|
|
|
18,226 |
|
|
|
16,453 |
|
Trade
accounts receivable, net
|
|
|
115,452 |
|
|
|
108,900 |
|
Inventories,
net
|
|
|
104,263 |
|
|
|
93,952 |
|
Deferred
income taxes
|
|
|
11,373 |
|
|
|
11,373 |
|
Prepaid
expenses and other current assets
|
|
|
22,674 |
|
|
|
25,035 |
|
Total
current assets
|
|
|
298,719 |
|
|
|
280,777 |
|
Investments
|
|
|
4,427 |
|
|
|
4,427 |
|
Property,
plant and equipment, net
|
|
|
35,257 |
|
|
|
33,444 |
|
Patents
and other intangible assets, net
|
|
|
225,082 |
|
|
|
230,305 |
|
Goodwill
|
|
|
318,665 |
|
|
|
319,938 |
|
Deferred
taxes and other long-term assets
|
|
|
17,205 |
|
|
|
16,773 |
|
Total
assets
|
|
$ |
899,355 |
|
|
$ |
885,664 |
|
Liabilities
and shareholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Bank
borrowings
|
|
$ |
10,844 |
|
|
$ |
8,704 |
|
Current
portion of long-term debt
|
|
|
3,340 |
|
|
|
3,343 |
|
Trade
accounts payable
|
|
|
29,117 |
|
|
|
24,715 |
|
Other
current liabilities
|
|
|
36,635 |
|
|
|
36,544 |
|
Total
current liabilities
|
|
|
79,936 |
|
|
|
73,306 |
|
Long-term
debt
|
|
|
290,065 |
|
|
|
294,588 |
|
Deferred
income taxes
|
|
|
74,398 |
|
|
|
75,908 |
|
Other
long-term liabilities
|
|
|
12,195 |
|
|
|
7,922 |
|
Total
liabilities
|
|
|
456,594 |
|
|
|
451,724 |
|
|
|
|
|
|
|
|
|
|
Contingencies
(Note 17)
|
|
|
|
|
|
|
|
|
Shareholders’
equity:
|
|
|
|
|
|
|
|
|
Common
shares (17,088,356 and 17,038,304 shares issued at March 31, 2008 and
December 31, 2007, respectively)
|
|
|
1,709 |
|
|
|
1,704 |
|
Additional
paid-in capital
|
|
|
161,362 |
|
|
|
157,349 |
|
Retained
earnings
|
|
|
261,807 |
|
|
|
258,201 |
|
Accumulated
other comprehensive income
|
|
|
17,883 |
|
|
|
16,686 |
|
Total
shareholders’ equity
|
|
|
442,761 |
|
|
|
433,940 |
|
Total
liabilities and shareholders’ equity
|
|
$ |
899,355 |
|
|
$ |
885,664 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
(Unaudited,
U.S. Dollars, in thousands except share and per share
data)
|
|
Three
Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$ |
128,032 |
|
|
$ |
117,032 |
|
Cost
of sales
|
|
|
34,238 |
|
|
|
30,796 |
|
Gross
profit
|
|
|
93,794 |
|
|
|
86,236 |
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
50,196 |
|
|
|
44,583 |
|
General
and administrative
|
|
|
22,180 |
|
|
|
15,906 |
|
Research
and development
|
|
|
6,354 |
|
|
|
6,337 |
|
Amortization
of intangible assets
|
|
|
5,043 |
|
|
|
4,468 |
|
Gain
on sale of Pain Care® operations
|
|
|
(1,570 |
) |
|
|
- |
|
|
|
|
82,203 |
|
|
|
71,294 |
|
Operating
income
|
|
|
11,591 |
|
|
|
14,942 |
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
|
|
|
|
|
|
Interest
income (expense), net
|
|
|
(5,390 |
) |
|
|
(5,664 |
) |
Other,
net
|
|
|
494 |
|
|
|
(556 |
) |
Other
income (expense), net
|
|
|
(4,896 |
) |
|
|
(6,220 |
) |
Income
before minority interests and income taxes
|
|
|
6,695 |
|
|
|
8,722 |
|
Minority
interests
|
|
|
- |
|
|
|
(43 |
) |
Income
before income taxes
|
|
|
6,695 |
|
|
|
8,679 |
|
Income
tax expense
|
|
|
(3,089 |
) |
|
|
(2,412 |
) |
Net
income
|
|
$ |
3,606 |
|
|
$ |
6,267 |
|
|
|
|
|
|
|
|
|
|
Net
income per common share - basic
|
|
$ |
0.21 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
Net
income per common share - diluted
|
|
$ |
0.21 |
|
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - basic
|
|
|
17,087,003 |
|
|
|
16,464,571 |
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - diluted
|
|
|
17,261,172 |
|
|
|
16,926,257 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
(Unaudited,
U.S. Dollars, in thousands)
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
income
|
|
$ |
3,606 |
|
|
$ |
6,267 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
7,397 |
|
|
|
6,937 |
|
Amortization
of debt costs
|
|
|
395 |
|
|
|
164 |
|
Provision
for doubtful accounts
|
|
|
1,156 |
|
|
|
876 |
|
Deferred
taxes
|
|
|
- |
|
|
|
(2,978 |
) |
Share-based
compensation
|
|
|
2,094 |
|
|
|
2,599 |
|
Minority
interest
|
|
|
88 |
|
|
|
(10 |
) |
Amortization
of step up of fair value in inventory
|
|
|
152 |
|
|
|
930 |
|
Gain
on sale of Pain Care® operations
|
|
|
(1,570 |
) |
|
|
- |
|
Other
|
|
|
(2,430 |
) |
|
|
(767 |
) |
Change
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
(1,773 |
) |
|
|
1,403 |
|
Accounts
receivable
|
|
|
(5,586 |
) |
|
|
(4,597 |
) |
Inventories
|
|
|
(8,447 |
) |
|
|
(8,224 |
) |
Prepaid
expenses and other current assets
|
|
|
2,627 |
|
|
|
(2,474 |
) |
Accounts
payable
|
|
|
3,809 |
|
|
|
(5,069 |
) |
Current
liabilities
|
|
|
(616 |
) |
|
|
6,539 |
|
Net
cash provided by operating activities
|
|
|
902 |
|
|
|
1,596 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Payments
made in connection with acquisitions and investments, net of cash
acquired
|
|
|
0 |
|
|
|
(985 |
) |
Capital
expenditures
|
|
|
(4,112 |
) |
|
|
(4,571 |
) |
Proceeds
from sale of Pain Care® operations
|
|
|
5,980 |
|
|
|
- |
|
Net
cash provided by (used in) investing activities
|
|
|
1,868 |
|
|
|
(5,556 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
proceeds from issue of common shares
|
|
|
1,907 |
|
|
|
1,637 |
|
Repayments
of long-term debt
|
|
|
(4,524 |
) |
|
|
(4,834 |
) |
Proceeds
from bank borrowings
|
|
|
1,361 |
|
|
|
2,631 |
|
Tax
benefit on non-qualified stock options
|
|
|
17 |
|
|
|
396 |
|
Other
|
|
|
0 |
|
|
|
- |
|
Net
cash used in financing activities
|
|
|
(1,239 |
) |
|
|
(170 |
) |
Effect
of exchange rate changes on cash
|
|
|
136 |
|
|
|
54 |
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
1,667 |
|
|
|
(4,076 |
) |
Cash
and cash equivalents at the beginning of the year
|
|
|
25,064 |
|
|
|
25,881 |
|
Cash
and cash equivalents at the end of the period
|
|
$ |
26,731 |
|
|
$ |
21,805 |
|
The
accompanying notes form an integral part of these condensed consolidated
financial statements.
NOTES
TO THE CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Orthofix
International N.V. (the “Company”) is a multinational corporation principally
involved in the design, development, manufacture, marketing and distribution of
medical devices, principally for the orthopedic products market.
NOTE
2:
|
BASIS
OF PRESENTATION
|
The
accompanying unaudited Condensed Consolidated Financial Statements have been
prepared in accordance with accounting principles generally accepted in the
United States for interim financial information and with the instructions to
Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules
and regulations, certain information and note disclosures, normally included in
financial statements prepared in accordance with accounting principles generally
accepted in the United States, have been condensed or omitted. In the
opinion of management, all adjustments (consisting of normal recurring items)
considered necessary for a fair presentation have been
included. Operating results for the three months ended March 31, 2008
are not necessarily indicative of the results that may be expected for the year
ending December 31, 2008. The balance sheet at December 31, 2007 has
been derived from the audited financial statements at that date but does not
include all of the information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements. For further information, refer to the Consolidated
Financial Statements and Notes thereto of the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2007.
NOTE
3:
|
RECENTLY
ISSUED ACCOUNTING STANDARDS
|
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value
Measurements.” The Statement defines fair value, establishes a
framework for measuring fair value in generally accepted accounting principles
and expands disclosure related to the use of fair value measures in financial
statements. The provisions of SFAS No. 157 were to be effective for
fiscal years beginning after November 15, 2007. On February 6, 2008,
the FASB agreed to defer the effective date of SFAS No. 157 for one year for
certain nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on a recurring
basis (at least annually). Effective January 1, 2008, the Company
adopted SFAS No. 157 except as it applies to those nonfinancial assets and
nonfinancial liabilities. The adoption of SFAS No. 157 did not have a
material impact on the Company’s results of operations or financial
position.
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities – including an amendment of FASB
Statement No. 115.” SFAS No. 159 allows an entity the irrevocable
option to elect fair value for the initial and subsequent measurement of certain
financial assets and liabilities under an instrument-by-instrument
election. Subsequent measurements for the financial assets and
liabilities an entity elects to fair value will be recognized in the results of
operations. SFAS No. 159 also establishes additional disclosure
requirements. The Company did not elect the fair value option under
SFAS No. 159 for any of its financial assets or liabilities upon
adoption. The adoption of SFAS No. 159 did not have a material impact
on the Company’s results of operations or financial position.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities, an amendment of FASB Statement No. 133”. SFAS
No. 161 requires entities to provide greater transparency through additional
disclosures about (a) how and why an entity uses derivative instruments, (b) how
derivative instruments and related hedged items are accounted for under SFAS No.
133 “Accounting for Derivative Instruments and Hedging Activities” and its
related interpretations, and (c) how derivative instruments and related hedged
items affect an entity’s financial position, results of operations, and cash
flows. SFAS No. 161 is effective for financial statements issued for
fiscal years and interim periods beginning after November 15, 2008. The Company
is currently evaluating the potential impact of adopting SFAS No. 161 on the
Company’s disclosures of its derivative instruments and hedging
activities.
In
December 2007, the Financial Accounting Standards Board (“FASB”) issued SFAS No.
141(R), “Business Combinations (revised 2007).” SFAS No. 141(R)
amends SFAS No. 141, “Business Combinations,” and provides revised guidance for
recognizing and measuring identifiable assets and goodwill acquired, liabilities
assumed, and any noncontrolling interest in the acquiree. It also
provides disclosure requirements to enable users of the financial statements to
evaluate the nature and financial effects of the business
combination. SFAS No. 141(R) is effective for fiscal years beginning
after December 15, 2008 and is to be applied prospectively. The
Company is currently evaluating the potential impact of adopting SFAS No. 141(R)
on its consolidated financial position and results of operations.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements, an Amendment of ARB 51,” which establishes
accounting and reporting standards pertaining to ownership interest in
subsidiaries held by parties other than the parent, the amount of net income
attributable to the parent and to the noncontrolling interest, changes in a
parent’s ownership interest, and the valuation of any retained noncontrolling
equity investment when a subsidiary is deconsolidated. SFAS No. 160
also establishes disclosure requirements that clearly identify and distinguish
between the interests of the parent and the interests of the noncontrolling
owners. SFAS No. 160 is effective for fiscal years beginning on or
after December 15, 2008. The Company is currently evaluating the
potential impact of adopting SFAS No. 160 on its consolidated financial position
and results of operations.
NOTE
4:
|
SHARE-BASED
COMPENSATION
|
The
Company accounts for its share-based compensation plans in accordance with SFAS
No. 123(R), “Share-Based Payment”, using the modified prospective transition
method. Under SFAS No. 123(R), all share-based compensation costs are
measured at the grant date, based on the estimated fair value of the award, and
are recognized as expense in the statement of operations over the requisite
service period. Commencing in June 2007, the Company offered
restricted shares in addition to stock options as a form of share-based
compensation.
The
following table shows the detail of share-based compensation by line item in the
Condensed Consolidated Statements of Operations for the three months ended March
31, 2008 and 2007:
(In
US$ thousands)
|
|
Three
Months Ended
March
31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
$ |
113 |
|
|
$ |
89 |
|
|
|
|
|
|
|
|
|
|
Sales
and marketing (1)
|
|
|
184 |
|
|
|
551 |
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
1,564 |
|
|
|
1,592 |
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
233 |
|
|
|
367 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
2,094 |
|
|
$ |
2,599 |
|
|
(1)
|
There
are no performance requirements and there was no consideration received
for share-based compensation awarded to sales and marketing
employees.
|
NOTE
5:
|
RECLASSIFICATIONS
|
Certain
prior year amounts have been reclassified to conform to the 2008
presentation. The reclassifications have no effect on previously
reported net income or shareholders’ equity.
Inventories
are valued at the lower of cost or estimated net realizable value, after
provision for excess or obsolete items. Cost is determined on a
weighted-average basis, which approximates the FIFO method. The
valuation of work-in-process, finished goods, field inventory and consignment
inventory includes the cost of materials, labor and production. Field
inventory represents immediately saleable finished goods inventory that is in
the possession of the Company’s direct sales representatives.
Inventories
were as follows:
|
|
March 31,
|
|
|
December 31,
|
|
(In
US$ thousands)
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
$ |
9,832 |
|
|
$ |
10,804 |
|
Work-in-process
|
|
|
7,836 |
|
|
|
6,100 |
|
Finished
goods
|
|
|
47,163 |
|
|
|
42,384 |
|
Field
inventory (as described above)
|
|
|
13,461 |
|
|
|
13,997 |
|
Consignment
inventory
|
|
|
35,748 |
|
|
|
30,560 |
|
|
|
|
114,040 |
|
|
|
103,845 |
|
Less
reserve for obsolescence
|
|
|
(9,777 |
) |
|
|
(9,893 |
) |
|
|
$ |
104,263 |
|
|
$ |
93,952 |
|
The
changes in the net carrying value of goodwill by reportable segment for the
period ended March 31, 2008 are as follows:
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At
December 31, 2007
|
|
$ |
31,793 |
|
|
$ |
136,240 |
|
|
$ |
101,322 |
|
|
$ |
50,583 |
|
|
$ |
319,938 |
|
Disposals
(1)
|
|
|
- |
|
|
|
- |
|
|
|
(2,027 |
) |
|
|
- |
|
|
|
(2,027 |
) |
Purchase
price adjustment (2)
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(365 |
) |
|
|
(365 |
) |
Foreign
currency
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,119 |
|
|
|
1,119 |
|
At
March 31, 2008
|
|
$ |
31,793 |
|
|
$ |
136,240 |
|
|
$ |
99,295 |
|
|
$ |
51,337 |
|
|
$ |
318,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Sale
of operations relating to the Pain Care® business at
Breg.
|
(2)
|
Principally
relates to the recording of inventory at fair value in connection with the
acquisition of the remaining 38.74% of the minority interest in the
Company’s Mexican subsidiary.
|
|
|
March
31,
|
|
|
December 31,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
Borrowings
under line of credit
|
|
$ |
10,844 |
|
|
$ |
8,704 |
|
The
weighted average interest rates on borrowings under lines of credit as of March
31, 2008 and December 31, 2007 were 4.96% and 4.79%, respectively.
Borrowings
under lines of credit consist of borrowings in Euros. The Company had
unused available lines of credit of 0.4 million Euros ($0.7 million) and 1.3
million Euros ($2.0 million) at March 31, 2008 and December 31, 2007,
respectively, in its Italian line of credit, which gives the Company the option
to borrow amounts in Italy at rates which are determined at the time of
borrowing. This line of credit is unsecured.
(In
US$ thousands)
|
|
March 31,
2008
|
|
|
December 31,
2007
|
|
|
|
|
|
|
|
|
Long-term
obligations
|
|
$ |
293,175 |
|
|
$ |
297,700 |
|
Other
loans
|
|
|
230 |
|
|
|
231 |
|
|
|
|
293,405 |
|
|
|
297,931 |
|
Less
current portion
|
|
|
(3,340 |
) |
|
|
(3,343 |
) |
|
|
$ |
290,065 |
|
|
$ |
294,588 |
|
On
September 22, 2006 the Company’s wholly-owned U.S. holding company subsidiary,
Orthofix Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured
credit facility with a syndicate of financial institutions to finance the
acquisition of Blackstone. The senior secured credit facility
provides for (1) a seven-year amortizing term loan facility of $330.0 million,
the proceeds of which, together with cash balances were used for payment of the
purchase price of Blackstone; and (2) a six-year revolving credit facility of
$45.0 million. As of March 31, 2008, the Company had no amounts
outstanding under the revolving credit facility and $293.2 million outstanding
under the term loan facility. Obligations under the senior secured
credit facility have a floating interest rate of the London Inter-Bank Offered
Rate (“LIBOR”) plus a margin or prime rate plus a margin. Currently,
the term loan is a LIBOR loan, and the margin is 1.75%, which is adjusted
quarterly based upon the leverage ratio of the Company and its
subsidiaries. The effective interest rates as of March 31, 2008 and
December 31, 2007 on the senior secured credit facility were 4.46% and 6.58%,
respectively.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) have guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
In
conjunction with obtaining the senior secured credit facility and the amendment
thereto, the Company incurred debt issuance costs of $6.5 million. As
of March 31, 2008, $4.7 million of capitalized debt issuance costs is included
in other long-term assets compared to $5.2 million at December 31,
2007.
Certain
subsidiaries of the Company have restrictions on their ability to pay dividends
or make intercompany loan advances pursuant to the Company’s senior secured
credit facility. The net assets of Orthofix Holdings and its
subsidiaries are restricted for distributions to the parent
company. Domestic subsidiaries of the Company as parties to the
credit agreement have access to these net assets for operational
purposes. The amount of restricted net assets of Orthofix Holdings
and its subsidiaries as of March 31, 2008 is $289.0 million compared to $300.7
million at December 31, 2007.
For the
three months ended March 31, 2008, the Company issued 50,052 shares of common
stock upon the exercise of outstanding stock options and shares issued pursuant
to its employee stock purchase plan for net proceeds of $1.9
million.
NOTE
11:
|
COMPREHENSIVE
INCOME (LOSS)
|
Accumulated
other comprehensive income (loss) is comprised of foreign currency translation
adjustments and the effective portion of the gain (loss) for derivatives
designated and accounted for as a cash flow hedge. The components of
and changes in other comprehensive income (loss) are as follows:
(In
US$ thousands)
|
|
Foreign
Currency Translation Adjustments
|
|
|
Fair
Value of Derivatives
|
|
|
Accumulated
Other Comprehensive Income/(Loss)
|
|
Balance
at December 31, 2007
|
|
$ |
15,156 |
|
|
$ |
1,530 |
|
|
$ |
16,686 |
|
Unrealized
gain on derivative instrument, net of tax of $1,098
|
|
|
- |
|
|
|
2,824 |
|
|
|
2,824 |
|
Foreign
currency translation adjustment
|
|
|
(1,627 |
) |
|
|
- |
|
|
|
(1,627 |
) |
Balance
at March 31, 2008
|
|
$ |
13,529 |
|
|
$ |
4,354 |
|
|
$ |
17,883 |
|
(In
US$ thousands)
|
|
Three
Months Ended
March
31,
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
3,606 |
|
|
$ |
6,267 |
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income:
|
|
|
|
|
|
|
|
|
Unrealized
gain (loss) on derivative instrument, net of tax
|
|
|
2,824 |
|
|
|
(203 |
) |
Foreign
currency translation adjustment
|
|
|
(1,627 |
) |
|
|
2,097 |
|
Total
comprehensive income
|
|
$ |
4,803 |
|
|
$ |
8,161 |
|
NOTE
12:
|
BUSINESS
SEGMENT INFORMATION
|
The
Company’s segment information is prepared on the same basis that the Company’s
management reviews the financial information for operational decision making
purposes. Concurrent with the acquisition of Blackstone, the Company redefined
its business segments and market sectors. All prior period
information presented has been restated to conform to the new segments and
market sectors. The Company is comprised of the following
segments:
Orthofix
Domestic
Orthofix
Domestic (“Domestic”) consists of operations in the United States of Orthofix
Inc., which designs, manufactures and distributes stimulation and orthopedic
products. Domestic uses both direct and distributor sales
representatives to sell Spine and Orthopedic products to hospitals, doctors and
other healthcare providers in the United States market.
Blackstone
Blackstone
(“Blackstone”) consists of Blackstone Medical, Inc., based in Springfield,
Massachusetts. Blackstone specializes in the design, development and marketing
of spinal implant and related human cellular and tissue based products (“HCT/P
products”, often referred to as Biologic products). Blackstone's operating loss
includes amortization of acquired intangible assets and in the first quarter of
2007, it also includes inventory which has been stepped-up in value for the
Blackstone acquisition. Blackstone distributes its products through a network of
domestic and international distributors, sales representatives and
affiliates.
Breg
Breg
(“Breg”) consists of Breg, Inc. Breg, based in Vista, California, designs,
manufactures, and distributes orthopedic products for post-operative
reconstruction and rehabilitative patient use and sells its products through a
network of domestic and international distributors, sales representatives and
affiliates.
Orthofix
International
Orthofix
International (“International”) consists of international operations located in
Europe, Mexico, Brazil and Puerto Rico, as well as independent distributors
located outside the United States. International uses both direct and
distributor sales representatives to sell Spine, Orthopedics, Sports Medicine,
Vascular and Other products to hospitals, doctors, and other healthcare
providers.
Group
Activities
Group
Activities are comprised of the Parent’s and Orthofix Holdings’ operating
expenses and identifiable assets.
The
tables below present information by reportable segment for the three months
ended March 31:
|
|
External
Sales
|
|
|
|
|
(In
US$ thousands)
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$ |
44,127 |
|
|
$ |
39,115 |
|
|
$ |
1,621 |
|
|
$ |
989 |
|
Blackstone
|
|
|
27,981 |
|
|
|
25,866 |
|
|
|
1,524 |
|
|
|
702 |
|
Breg
|
|
|
22,063 |
|
|
|
20,123 |
|
|
|
1,538 |
|
|
|
473 |
|
International
|
|
|
33,861 |
|
|
|
31,928 |
|
|
|
5,499 |
|
|
|
8,413 |
|
Total
|
|
$ |
128,032 |
|
|
$ |
117,032 |
|
|
$ |
10,182 |
|
|
$ |
10,577 |
|
Operating
Income (Loss)
|
|
Three
Months Ended
March
31,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
Domestic
|
|
$ |
14,133 |
|
|
$ |
12,726 |
|
Blackstone
|
|
|
(3,731 |
) |
|
|
(614 |
) |
Breg
|
|
|
4,371 |
|
|
|
1,557 |
|
International
|
|
|
4,488 |
|
|
|
6,077 |
|
Group
Activities
|
|
|
(7,816 |
) |
|
|
(3,499 |
) |
Eliminations
|
|
|
146 |
|
|
|
(1,305 |
) |
Total
|
|
$ |
11,591 |
|
|
$ |
14,942 |
|
|
|
Sales
by Market Sector
for
the three month period ended March 31, 2008
|
|
|
|
|
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
33,373 |
|
|
$ |
27,981 |
|
|
$ |
- |
|
|
$ |
1,104 |
|
|
$ |
62,458 |
|
Orthopedics
|
|
|
10,754 |
|
|
|
- |
|
|
|
- |
|
|
|
19,034 |
|
|
|
29,788 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
22,063 |
|
|
|
1,252 |
|
|
|
23,315 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,333 |
|
|
|
5,333 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
7,138 |
|
|
|
7,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
44,127 |
|
|
$ |
27,981 |
|
|
$ |
22,063 |
|
|
$ |
33,861 |
|
|
$ |
128,032 |
|
|
|
Sales
by Market Sector
for
the three month period ended March 31, 2007
|
|
|
|
|
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
29,604 |
|
|
$ |
25,866 |
|
|
$ |
- |
|
|
$ |
679 |
|
|
$ |
56,149 |
|
Orthopedics
|
|
|
9,511 |
|
|
|
- |
|
|
|
- |
|
|
|
18,134 |
|
|
|
27,645 |
|
Sports
Medicine
|
|
|
- |
|
|
|
- |
|
|
|
20,123 |
|
|
|
1,035 |
|
|
|
21,158 |
|
Vascular
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,921 |
|
|
|
4,921 |
|
Other
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
7,159 |
|
|
|
7,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
39,115 |
|
|
$ |
25,866 |
|
|
$ |
20,123 |
|
|
$ |
31,928 |
|
|
$ |
117,032 |
|
The
difference between the reported provision for income taxes and a provision
computed by applying the statutory rates applicable to each subsidiary of the
Company is primarily attributable to an unfavorable discrete tax item resulting
from a taxable gain on the sale of the Company’s Pain Care®
operations. Further, the effective tax rate has been positively
affected by the Company’s European restructuring in 2006 and a similar
transaction in 2002, whereby certain intangible assets were sold between
subsidiaries in order to optimize the Company’s supply chain. Such
assets were sold at estimates of fair value based upon valuations which remain
subject to review by the local taxing authorities. Further, the
effective tax rate has been affected by the generation of un-utilizable net
operating losses in various jurisdictions, and the Section 199 deduction related
to income attributable to production activities occurring in the United
States.
As of
March 31, 2008, the Company’s gross unrecognized tax benefit was $1.7 million
plus $0.5 million accrued for interest and penalties. The entire $1.7
million of unrecognized tax benefit would affect the Company’s effective tax
rate if recognized. The Company believes it is reasonably possible
that $1.0 million of its gross unrecognized tax benefit will decrease during the
twelve months ending December 31, 2008 if certain statutes of limitations expire
during 2008.
The
Company recognizes accrued interest and penalties related to unrecognized tax
benefits within its global operations in income tax expense. To
the extent interest and penalties are not assessed with respect to uncertain tax
positions, amounts accrued will be reduced and reflected as a reduction of the
overall income tax provision.
The
Company is subject to tax examinations in all major taxing jurisdictions in
which it operates. The Company files a consolidated income tax return
in the U.S. federal jurisdiction and numerous consolidated and separate income
tax returns in many state and foreign jurisdictions. The following table
summarizes these open tax years by major jurisdiction:
|
|
Open
Tax Year
|
|
|
Examination
in
|
|
Examination
not yet
|
Jurisdiction
|
|
Progress
|
|
Initiated
|
|
|
|
|
|
United
States
|
|
2004-2006
|
|
2007
|
|
|
|
|
|
Various
States
|
|
1996-2005
|
|
1996-2007
|
|
|
|
|
|
Brazil
|
|
N/A
|
|
2004-2007
|
|
|
|
|
|
Cyprus
|
|
N/A
|
|
2005-2007
|
|
|
|
|
|
France
|
|
N/A
|
|
2002-2007
|
|
|
|
|
|
Germany
|
|
2003-2005
|
|
2006-2007
|
|
|
|
|
|
Italy
|
|
N/A
|
|
2003-2007
|
|
|
|
|
|
Mexico
|
|
N/A
|
|
2000-2007
|
|
|
|
|
|
Netherlands
|
|
N/A
|
|
2004-2007
|
|
|
|
|
|
Puerto
Rico
|
|
N/A
|
|
N/A
|
|
|
|
|
|
Seychelles
|
|
N/A
|
|
N/A
|
|
|
|
|
|
Switzerland
|
|
N/A
|
|
2004-2007
|
|
|
|
|
|
United
Kingdom
|
|
N/A
|
|
2005-2007
|
NOTE
14:
|
EARNINGS
PER SHARE
|
For the
three months ended March 31, 2008 and 2007, there were no adjustments to net
income for purposes of calculating basic and diluted net income per common
share. The following table is a reconciliation of the weighted
average shares used in the basic and diluted net income per common share
computations.
|
|
Three
Months Ended
March
31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares - basic
|
|
|
17,087,003 |
|
|
|
16,464,571 |
|
Effect
of dilutive securities
|
|
|
174,169 |
|
|
|
461,686 |
|
Weighted
average common shares – diluted
|
|
|
17,261,172 |
|
|
|
16,926,257 |
|
The
Company did not include 260,668 and 10,500 options in the diluted shares
outstanding calculation for the three months ended March 31, 2008 and 2007,
respectively, because their inclusion would have been
anti-dilutive.
NOTE
15:
|
DERIVATIVE
INSTRUMENTS
|
In 2006,
the Company entered into a cross-currency swap agreement to manage its foreign
currency exposure related to a portion of the Company’s intercompany receivable
of a U.S. dollar functional currency subsidiary that is denominated in
Euro. The derivative instrument, a ten-year fully amortizable
agreement with a notional amount of $63.0 million is scheduled to expire on
December 30, 2016. The instrument is designated as a cash flow
hedge. The amount outstanding under the agreement as of March 31,
2008 is $59.8 million. Under the agreement, the Company pays Euro and
receives U.S. dollars based on scheduled cash flows in the
agreement. The Company recognized the unrealized gain on the change
in fair value of this swap arrangement of $2.8 million, net of tax, within other
comprehensive income for the three months ended March 31, 2008.
NOTE
16:
|
FAIR
VALUE MEASUREMENTS
|
As
described in Note 3, “Recently Issued Accounting Standards,” the Company adopted
SFAS No. 157 effective January 1, 2008. SFAS No. 157 defines fair
value as the price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous market for the
asset or liability in an orderly transaction between market participants on the
measurement date. SFAS No. 157 also describes three levels of inputs
that may be used to measure fair value:
Level 1 –
quoted prices in active markets for identical assets and
liabilities
Level 2 –
observable inputs other than quoted prices in active markets for identical
assets and liabilities
Level 3 –
unobservable inputs in which there is little or no market data available, which
require the reporting entity to develop its own
assumptions
The fair
value of the Company’s financial assets and liabilities measured at fair value
on a recurring basis were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Equivalents
|
|
$ |
7,122 |
|
|
$ |
7,122 |
|
|
$ |
- |
|
|
$ |
- |
|
Derivative
Financial Instruments(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flow Hedges
|
|
$ |
(8,485 |
) |
|
|
- |
|
|
|
(8,485 |
) |
|
|
- |
|
(1) See
Note 15, “Derivative Instruments”.
Litigation
Effective
October 29, 2007, the Company’s subsidiary, Blackstone, entered into a
settlement agreement with respect to a patent infringement lawsuit captioned
Medtronic Sofamor Danek USA Inc., Warsaw Orthopedic, Inc., Medtronic Puerto Rico
Operations Co., and Medtronic Sofamor Danek Deggendorf, GmbH v. Blackstone
Medical, Inc., Civil Action No. 06-30165-MAP, filed on September 22, 2006 in the
United States District Court for the District of Massachusetts. In that lawsuit,
the plaintiffs had alleged that (i) they were the exclusive licensees of United
States Patent Nos. 6,926,718 B1, 6,936,050 B2, 6,936,051 B2, 6,398,783 B1 and
7,066,961 B2 (the “Patents”), and (ii) Blackstone's making, selling, offering
for sale, and using within the United States of its Blackstone Anterior Cervical
Plate, 3º Anterior Cervical Plate, Hallmark Anterior Cervical Plate and Construx
Mini PEEK VBR System products infringed the Patents, and that such infringement
was willful. The Complaint requested both damages and an injunction
against further alleged infringement of the Patents. The Complaint did not
specifically state an amount of damages. Blackstone denied
infringement and asserted that the Patents were invalid. On July 20,
2007, the Company submitted a claim for indemnification from the escrow fund
established in connection with the agreement and plan of merger between the
Company, New Era Medical Corp. and Blackstone, dated as of August 4, 2006 (the
“Merger Agreement”), for any losses to the Company or Blackstone resulting from
this matter. The Company was subsequently notified by legal counsel
for the former shareholders that the representative of the former shareholders
of Blackstone has objected to the indemnification claim and intends to contest
it in accordance with the terms of the Merger Agreement. The Company
is unable to predict the outcome of the escrow claim or to estimate the amount,
if any, that may ultimately be returned to the Company from the escrow
fund. The settlement agreement is not expected to have a material
impact on the Company’s consolidated financial position, results of operations
or cash flows.
On or
about July 23, 2007, Blackstone received a subpoena issued by the Department of
Health and Human Services, Office of Inspector General, under the authority of
the federal healthcare anti-kickback and false claims statutes. The
subpoena seeks documents for the period January 1, 2000 through July 31, 2006
which is prior to Blackstone’s acquisition by the Company. The
Company believes that the subpoena concerns the compensation of physician
consultants and related matters. Blackstone is cooperating with the
government’s request and is in the process of responding to the
subpoena. The Company is unable to predict what action, if any, might
be taken in the future by the Department of Health and Human Services, Office of
Inspector General or other governmental authorities as a result of this
investigation or what impact, if any, the outcome of this matter might have on
its consolidated financial position, results of operations, or cash
flows. On September 17, 2007, the Company submitted a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any losses to the Company or Blackstone resulting from this
matter. The Company was subsequently notified by legal counsel for
the former shareholders that the representative of the former shareholders of
Blackstone has objected to the indemnification claim and intends to contest it
in accordance with the terms of the Merger Agreement. The Company is
unable to predict the outcome of the escrow claim or to estimate the amount, if
any, that may ultimately be returned to the Company from the escrow
fund.
On or
about January 7, 2008, the “Company received a federal grand jury subpoena from
the United States Attorney’s Office for the District of
Massachusetts. The subpoena seeks documents for the period January 1,
2000 through July 15, 2007 from the Company, including its
subsidiaries. The Company believes that the subpoena concerns the
compensation of physician consultants and related matters, and further believes
that it is associated with Department of Health and Human Services, Office of
Inspector General’s investigation of such matters. The Company is
cooperating with the government’s request and is in the process of responding to
the subpoena. The Company is unable to predict what action, if any,
might be taken in the future by governmental authorities as a result of this
investigation or what impact, if any, the outcome of this matter might have on
its consolidated financial position, results of operations, or cash
flows. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the United States’ Attorney’s Office for the District of Nevada
(“USAO-Nevada”). The subpoena seeks documents for the period from January 1999
to the present. The Company believes that the subpoena concerns payments or
gifts made by Blackstone to certain physicians. Blackstone is cooperating with
the government’s request and is in the process of responding to the
subpoena. The Company is unable to predict what action, if any, might
be taken in the future by the USAO-Nevada or other governmental authorities as a
result of this investigation or what impact, if any, the outcome of this matter
might have on its consolidated financial position, results of operations, or
cash flows. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
On
February 29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from
the Massachusetts Attorney General’s Office, Public Protection and Advocacy
Bureau, Healthcare Division. The Company believes that the CID seeks
documents concerning Blackstone’s financial relationships with certain
physicians and related matters for the period from March 2004 through the date
of issuance of the CID. The Company is cooperating with the
government’s request and is in the process of responding to the
CID. It is the Company’s intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to the Company or Blackstone resulting from
this matter.
By order
entered on January 4, 2007, the United States District Court for the Eastern
District of Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et
al., 4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. A qui tam action is
a civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. The complaint
alleges causes of action under the False Claims Act for alleged inappropriate
payments and other items of value conferred on Dr. Chan. On December
29, 2006, the U.S. Department of Justice filed a notice of non-intervention in
the case. Plaintiff subsequently amended the complaint to add the
Company as a defendant. On January 3, 2008, Dr. Chan pled guilty to
one count of knowingly soliciting and receiving kickbacks from a medical device
distributor in a criminal matter, in which neither the Company nor any of its
business units or employees were defendants In January 2008, Dr. Chan
entered into a settlement agreement with the plaintiff and certain governmental
entities in the civil qui tam action, and on February 21, 2008, a joint
stipulation of dismissal of claims against Dr. Chan in the action was filed with
the court, which removes him as a defendant in the action. The
Company believes Blackstone and the Company have meritorious defenses to the
claims alleged and the Company intends to defend vigorously against this
lawsuit. On September 17, 2007, the Company submitted a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any losses to the Company or Blackstone resulting from this
matter. The Company was subsequently notified by legal counsel for
the former shareholders that the representative of the former shareholders of
Blackstone has objected to the indemnification claim and intends to contest it
in accordance with the terms of the Merger Agreement. The Company is
unable to predict the outcome of the escrow claim or to estimate the amount, if
any, that may ultimately be returned to the Company from the escrow
fund.
Between
January 2007 and May 2007, Blackstone and Orthofix Inc. were named defendants,
along with other medical device manufacturers, in three civil lawsuits alleging
that Dr. Chan had performed unnecessary surgeries in three different
instances. In January 2008, the Company learned that Orthofix Inc.
was named a defendant, along with other medical device manufacturers, in a
fourth civil lawsuit alleging that Dr. Chan had performed unnecessary
surgeries. All four civil lawsuits have been served and are pending
in the Circuit Court of White County, Arkansas. The Company believes
that the Company and its subsidiaries have meritorious defenses to the claims
alleged and the Company and its subsidiaries intend to defend vigorously against
these lawsuits. On September 17, 2007, the Company submitted a claim
for indemnification from the escrow fund established in connection with the
Merger Agreement for any losses to the Company or Blackstone resulting from one
of these four civil lawsuits. The Company was subsequently notified
by legal counsel for the former shareholders that the representative of the
former shareholders of Blackstone has objected to the indemnification claim and
intends to contest it in accordance with the terms of the Merger
Agreement. The Company is unable to predict the outcome of the escrow
claim or to estimate the amount, if any, that may ultimately be returned to the
Company from the escrow fund.
Of the
total Blackstone purchase price, $50.0 million was placed into an escrow
account. As described in the Agreement and Plan of Merger, the
Company can make claims for reimbursement from the escrow account for certain
defined items relating to the acquisition for which the Company is
indemnified. As described in Note 16, the Company has certain
contingencies arising from the acquisition that management expects will be
reimbursable from the escrow account should the Company have to make a payment
to a third party. The Company records the claims against the escrow
in an escrow receivable account which is included in other current assets on the
consolidated balance sheets. Because the Company believes that the
settlement process of escrow claims is complex and all claims may not be
reimbursed, management has recorded a reserve against the escrow
receivable. Further, management believes that the amount that it will
be required to pay relating to the contingencies will not exceed the amount of
the escrow account; however, there can be no assurance that the contingencies
will not exceed the amount of the escrow account.
In
addition to the foregoing, the Company has submitted claims for indemnification
from the escrow fund established in connection with the Merger Agreement for
losses that have or may result from certain claims against Blackstone alleging
that plaintiffs and/or claimants were entitled to payments for Blackstone stock
options not reflected in Blackstone's corporate ledger at the time of
Blackstone's acquisition by the Company. To date, the representative
of the former shareholders of Blackstone has not objected to approximately $1.5
million in claims from the escrow fund, with certain claims remaining
pending.
The
Company cannot predict the outcome of any proceedings or claims made against the
Company or its subsidiaries and there can be no assurance that the ultimate
resolution of any claim will not have a material adverse impact on its
consolidated financial position, results of operations, or cash
flows.
In
addition to the foregoing, in the normal course of our business, the Company is
involved in various lawsuits from time to time and may be subject to certain
other contingencies.
United
Kingdom Payroll Taxes
In 2007,
Intavent Orthofix Limited, the Company’s UK distribution subsidiary, received an
inquiry from H.M. Revenue and Customs (HMRC) relating to the tax treatment of
gains made by UK employees on the exercise of stock options. The
Company is in the process of formulating a response to HMRC. Based on
preliminary calculations, a provision of $0.5 million has been provided, of
which the Company has paid $0.2 million. The Company cannot predict
the ultimate outcome of its discussions with HMRC.
Concentrations
of credit risk
There
have been no material changes from the information provided in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2007.
The
following discussion and analysis addresses our liquidity, financial condition,
and the results of our operations for the three months ended March 31, 2008
compared to our results of operations for the three months ended March 31,
2007. These discussions should be read in conjunction with our
historical consolidated financial statements and related notes thereto and the
other financial information included in this Form 10-Q and in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2007.
General
We are a
diversified orthopedic products company offering a broad line of surgical and
non-surgical products for the Spine, Orthopedics, Sports Medicine and Vascular
market sectors. Our products are designed to address the lifelong bone-and-joint
health needs of patients of all ages, helping them achieve a more active and
mobile lifestyle. We design, develop, manufacture, market and distribute medical
equipment used principally by musculoskeletal medical specialists for orthopedic
applications. Our main products are invasive and minimally invasive spinal
implant products and related human cellular and tissue based products (“HCT/P products”),
non-invasive bone growth stimulation products used to enhance the success rate
of spinal fusions and to treat non-union fractures, external and internal
fixation devices used in fracture treatment, limb lengthening and bone
reconstruction; and bracing products used for ligament injury prevention, pain
management and protection of surgical repair to promote faster healing. Our
products also include a device for enhancing venous circulation, cold therapy,
bone cement and devices for removal of bone cement used to fix artificial
implants and airway management products used in anesthesia
applications.
We have
administrative and training facilities in the United States and Italy and
manufacturing facilities in the United States, the United Kingdom, Italy and
Mexico. We directly distribute our products in the United States, the
United Kingdom, Italy, Germany, Switzerland, Austria, France, Belgium, Mexico,
Brazil, and Puerto Rico. In several of these and other markets, we
also distribute our products through independent distributors.
Our
condensed consolidated financial statements include the financial results of the
Company and its wholly-owned and majority-owned subsidiaries and entities over
which we have control. All intercompany accounts and transactions are
eliminated in consolidation.
Our
reporting currency is the United States Dollar. All balance sheet
accounts, except shareholders’ equity, are translated at period-end exchange
rates, and revenue and expense items are translated at weighted average rates of
exchange prevailing during the period. Gains and losses resulting
from foreign currency transactions are included in other income
(expense). Gains and losses resulting from the translation of foreign
currency financial statements are recorded in the accumulated other
comprehensive income component of shareholders’ equity.
Our
financial condition, results of operations and cash flows are not significantly
impacted by seasonality trends. However, sales associated with
products for elective procedures appear to be influenced by the somewhat lower
level of such procedures performed in the late summer. Certain of the
Breg® bracing products experience greater demand in the fall and winter
corresponding with high school and college football schedules and winter
sports. In addition, we do not believe our operations will be
significantly affected by inflation. However, in the ordinary course
of business, we are exposed to the impact of changes in interest rates and
foreign currency fluctuations. Our objective is to limit the impact
of such movements on earnings and cash flows. In order to achieve
this objective, we seek to balance non-dollar income and
expenditures. During the first three months of 2008, we have used
derivative instruments to hedge certain foreign currency fluctuation
exposures. See Item 3 – “Quantitative and Qualitative Disclosures
About Market Risk.”
On
September 22, 2006, we completed the acquisition of Blackstone Medical, Inc.
(“Blackstone”), a privately held company specializing in the design, development
and marketing of spinal implant and related human cellular and tissue based
products (“HCT/P products”).
The purchase price for the acquisition was $333.0 million, subject to certain
closing adjustments, plus transaction costs and other accruals totaling
approximately $12.6 million as of March 31, 2008. The acquisition and related
costs were financed with $330.0 million of senior secured term debt and cash on
hand. Financing costs were approximately $6.5 million.
Effective
with the acquisition of Blackstone, we manage our operations as four business
segments: Domestic, Blackstone, Breg, and International. Domestic
consists of operations of our subsidiary Orthofix Inc. Blackstone
consists of Blackstone’s domestic operations and international
distributors. Breg consists of Breg Inc.’s domestic operations and
international distributors. International consists of
operations which are located in the rest of the world as well as independent
export distribution operations. Group Activities are comprised of the
operating expenses and identifiable assets of Orthofix International N.V. and
its U.S. holding company, Orthofix Holdings, Inc.
Segment
and Market Sector Revenues
The
following tables display net sales by business segment and net sales by market
sector. We keep our books and records and account for net sales,
costs of sales and expenses by business segment. We provide net sales
by market sector for information purposes only.
Business
Segment:
|
|
Three
Months Ended March 31,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Domestic
|
|
$ |
44,127 |
|
|
|
35 |
% |
|
$ |
39,115 |
|
|
|
33 |
% |
Blackstone
|
|
|
27,981 |
|
|
|
22 |
% |
|
|
25,866 |
|
|
|
23 |
% |
Breg
|
|
|
22,063 |
|
|
|
17 |
% |
|
|
20,123 |
|
|
|
17 |
% |
International
|
|
|
33,861 |
|
|
|
26 |
% |
|
|
31,928 |
|
|
|
27 |
% |
Total
|
|
$ |
128,032 |
|
|
|
100 |
% |
|
$ |
117,032 |
|
|
|
100 |
% |
Market
Sector:
|
|
Three
Months Ended March 31,
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Percent
of
Total
Net Sales
|
|
|
|
|
|
Percent
of Total Net Sales
|
|
Spine
|
|
$ |
62,458 |
|
|
|
49 |
% |
|
$ |
56,149 |
|
|
|
48 |
% |
Orthopedics
|
|
|
29,788 |
|
|
|
23 |
% |
|
|
27,645 |
|
|
|
24 |
% |
Sports
Medicine
|
|
|
23,315 |
|
|
|
18 |
% |
|
|
21,158 |
|
|
|
18 |
% |
Vascular
|
|
|
5,333 |
|
|
|
4 |
% |
|
|
4,921 |
|
|
|
4 |
% |
Other
|
|
|
7,138 |
|
|
|
6 |
% |
|
|
7,159 |
|
|
|
6 |
% |
Total
|
|
$ |
128,032 |
|
|
|
100 |
% |
|
$ |
117,032 |
|
|
|
100 |
% |
The
following table presents certain items from our Condensed Consolidated
Statements of Operations as a percent of total net sales for the periods
indicated:
|
|
Three
Months Ended March
31,
|
|
|
|
2008
(%)
|
|
|
2007
(%)
|
|
|
|
|
|
|
|
|
Net
sales
|
|
|
100
|
|
|
|
100
|
|
Cost
of sales
|
|
|
27
|
|
|
|
26
|
|
Gross
profit
|
|
|
73
|
|
|
|
74
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
39
|
|
|
|
38
|
|
General
and administrative
|
|
|
17
|
|
|
|
14
|
|
Research
and development
|
|
|
5
|
|
|
|
5
|
|
Amortization
of intangible assets
|
|
|
4
|
|
|
|
4
|
|
Gain
on sale of Pain Care® operations
|
|
|
(1)
|
|
|
|
-
|
|
Total
operating income
|
|
|
9
|
|
|
|
13
|
|
Net
income
|
|
|
3
|
|
|
|
5
|
|
Three
Months Ended March 31, 2008 Compared to Three Months Ended March 31,
2007
Net sales
increased 9% to $128.0 million for the first quarter of 2008 compared to $117.0
million for the first quarter of 2007. The impact of foreign currency
increased sales by $2.4 million during the first quarter of 2008 as compared to
the first quarter of 2007.
Sales
by Business Segment:
Net sales
in Domestic increased to $44.1 million in the first quarter of 2008 compared to
$39.1 million in the first quarter of 2007, an increase of
13%. Domestic’s net sales represented 35% of total net sales during
the first quarter of 2008 and 33% of total net sales for the first quarter of
2007. The increase in Domestic’s net sales was partially the result of a 13%
increase in sales in our Spine market sector, which was mainly driven by the
increase in sales of our Spinal-Stim® and Cervical-Stim®
products. The increase in Domestic’s net sales can also be attributed
to the 13% increase in our Orthopedic market sector as sales of our internal
fixation products including our eight-Plate Guided Growth System® increased 29%,
and sales of our Physio-Stim products increased 9% when compared to the first
quarter of 2007. These increases were partially offset by a 9%
decrease in sales of external fixation products when compared to the same period
in the prior year.
Domestic
Sales by Market Sector:
|
|
Net
Sales for the
Three
Months Ended March 31,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
33,373 |
|
|
$ |
29,604 |
|
|
|
13 |
% |
Orthopedics
|
|
|
10,754 |
|
|
|
9,511 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
44,127 |
|
|
$ |
39,115 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
in Blackstone increased to $28.0 million in the first quarter of 2008 compared
to $25.9 million in the first quarter of 2007, an increase of
8%. Blackstone’s net sales represented 22% of total net sales during
the first quarter of 2008 and 23% during the first quarter of
2007. The increase in Blackstone’s net sales can be mainly attributed
to an increase in the sales of our human cellular and tissue based products
(“HCT/P products”, often referred to as Biologic products). All of
Blackstone’s sales are recorded in our Spine market sector.
Net sales
in Breg increased $1.9 million to $22.1 million in the first quarter of 2008
compared to $20.1 million for the first quarter of 2007, an increase of
10%. Breg’s net sales represented 17% of total net sales during the
first quarters of both 2008 and 2007. The increase in Breg’s net
sales was primarily due to an increase in the sales of our Breg® bracing
products which increased 16% from the first quarter of 2007, primarily as a
result of the sales of our Fusion XT™ products. Further, sales of our
cold therapy products increased 12% when compared to the same period in the
prior year. These increases were partially offset by a 33% decrease
in sales of our pain therapy products as a result of the sale of operations
related to our Pain Care® line of ambulatory infusion pumps during March
2008. All of Breg’s sales are recorded in our Sports Medicine market
sector.
Net sales
in International increased 6% to $33.9 million in the first quarter of 2008
compared to $31.9 million in the first quarter of
2007. International’s net sales represented 26% and 27% of our total
net sales in the first quarter of 2008 and the first quarter of 2007,
respectively. The impact of foreign currency increased International net sales
by 9.1% or $2.3 million, during the first quarter of 2008 as compared to the
first quarter of 2007. In addition, International net sales in the
first quarter of 2008 were positively impacted by a 63% increase in our Spine
products mainly as a result of the sales of Blackstone products within
International, which increased from the comparable period in the prior
year. The sales of our Orthopedic products increased by 5% as
compared to the first quarter of 2007 primarily as a result of the sales of our
internal fixation products including the eight-Plate Guided Growth System®, which
increased 11%, as well as increased sales of our OSCAR and Physio-Stim®
products. Further, sales of Breg products within International,
included in the Sports Medicine sector, increased $0.2 million or 21% when
compared to first quarter of 2007. International sales in our
Vascular sector, which consists of the A-V Impulse System®, also
increased $0.4 million or 8% from the first quarter of 2007, while sales in our
Other sector, which includes the Laryngeal Mask, remained constant at
approximately $7.2 million.
International
Sales by Market Sector:
|
|
Net
Sales for the
Three
Months Ended March 31,
|
|
|
|
|
(In
US$ thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$ |
1,104 |
|
|
$ |
679 |
|
|
|
63 |
% |
Orthopedics
|
|
|
19,034 |
|
|
|
18,134 |
|
|
|
5 |
% |
Sports
Medicine
|
|
|
1,252 |
|
|
|
1,035 |
|
|
|
21 |
% |
Vascular
|
|
|
5,333 |
|
|
|
4,921 |
|
|
|
8 |
% |
Other
|
|
|
7,138 |
|
|
|
7,159 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
33,861 |
|
|
$ |
31,928 |
|
|
|
6 |
% |
Sales
by Market Sector:
Sales of
our Spine products increased 11% to $62.5 million in the first quarter of 2008
compared to $56.1 million in the first quarter of 2007. The increase
of $6.4 million is primarily due to increased sales of Blackstone products as
well as sales growth of spinal stimulation products in the United States
including the Cervical-Stim®. Spine product sales were 49% and 48% of
our total net sales in the first quarter of 2008 and 2007,
respectively.
Sales of
our Orthopedic products increased 8% to $29.8 million in the first quarter of
2008 compared to $27.6 million in the first quarter of 2007. The
increase of $2.2 million can be mainly attributed to a 16% increase in sales of
our internal fixation devices including the eight-Plate Guided Growth
System®. Further, the 11% increase in sales of our Physio-Stim®
products also contributed to the increase in our Orthopedic
sales. Offsetting these increases, our external fixation product
sales decreased by $0.5 million, or 4%, from the first quarter of
2007. Orthopedic product sales were 23% and 24% of our total net
sales in the first quarter of 2008 and 2007, respectively.
Sales of
our Sports Medicine products increased 10% to $23.3 million in the first quarter
of 2008 compared to $21.2 million in the first quarter of 2007. As
discussed above, the increase of $2.1 million is primarily due to sales of our
Breg® bracing products as well as our cold therapy products, offset by a
decrease in our pain therapy products, which can be mainly attributed to the
sale of operations relating to our Pain Care® line in March
2008. Sports Medicine product sales were 18% of our total net sales
in both the first quarter of 2008 and 2007.
Sales of
our Vascular products, which consist of our A-V Impulse System®, increased 8% to $5.3 million
in the first quarter of 2008 compared to $4.9 million in the first quarter of
2007. Vascular product sales were 4% of our total net sales in both
the first quarter of 2008 and 2007.
Sales of
our Other products, which include the sales of our Laryngeal Mask as well as our
Woman’s Care line, remained flat at approximately $7.2 million in the first
quarter of 2008 as compared to the first quarter of 2007. Other
product sales were 6% of our total net sales in both the first quarter of 2008
and 2007.
Gross Profit - Our gross
profit increased 9% to $93.8 million in the first quarter of 2008, from $86.2
million in the first quarter of 2007. The improvement in gross profit
can be primarily attributed to increased sales, as discussed above, as well as
stronger margins as a result of a favorable product mix. Sales of our spinal
stimulation products, which are our higher margin products, were up 13% from the
same period in the prior year. These increased margins were only
slightly offset by a decline in the margins of Blackstone’s products mainly due
to the impact of a changing sales mix with a higher percentage of overall sales
coming from lower profit Blackstone international distributors and Blackstone
domestic sales of HCT/P products. Further, during the first quarter
of 2007, we recorded a charge of $0.9 million for amortization of the step-up in
inventory associated with the Blackstone acquisition. Since the
step-up in the Blackstone inventory from purchase accounting was fully amortized
during 2007, no such amortization was recorded during the first quarter of
2008. Gross profit as a percent of net sales in the first quarter of
2008 was 73.3% compared to 73.7% in the first quarter of 2007.
Sales and Marketing Expense -
Sales and marketing expense, which includes commissions, royalties and the bad
debt provision, increased $5.6 million, or 13%, to $50.2 million in the first
quarter of 2008 compared to $44.6 million in the first quarter of
2007. This increase, which can be partly attributed to increased
expense in order to support increased sales activity, was also due to an
increase in commissions related to the completed exploration of the potential
divestiture of our orthopedic fixation business. Offsetting these
increases, SFAS 123(R) expense decreased $0.4 million from the comparable period
in the prior year. As a percent of sales, sales and marketing expense
was 39.2% in the first quarter of 2008 compared to 38.1% in the first quarter of
2007.
General and Administrative
Expense – General and administrative expense increased $6.3 million, or
39%, in the first quarter of 2008 to $22.2 million compared to $15.9 million in
the first quarter of 2007. The increase was primarily attributable to
a charge of $3.6 million in the first quarter of 2008 related to the completed
exploration of the potential divestiture of our orthopedic fixation business, as
well as increased audit fees and headcount, especially at our Brazilian and
Blackstone subsidiaries. General and administrative expense as a
percent of sales was 17.3% in the first quarter of 2008 compared to 13.6% in the
first quarter of 2007.
Research and Development
Expense - Research and development expense increased $0.1 million in the
first quarter of 2008 to $6.4 million compared to $6.3 million in the first
quarter of 2007. This increase was partially offset by a decrease in
SFAS 123(R) expense of $0.1 million from the comparable period in the prior
year. As a percent of sales, research and development expense
decreased to 5.0% in the first quarter of 2008 compared to 5.4% in the first
quarter of 2007.
Amortization of Intangible
Assets – Amortization of intangible assets increased $0.6 million, or
13%, in the first quarter of 2008 to $5.0 million compared to $4.5 million in
the first quarter of 2007. This increase can be primarily attributed
to an increase in the rate of amortization at Blackstone associated with
definite-lived intangible assets obtained in the Blackstone acquisition in
September 2006.
Gain on Sale of Pain Care®
Operations – Gain on sale of Pain Care® operations was $1.6 million in
the first quarter of 2008 and represented the gain on the sale of operations
related to our Pain Care® line of ambulatory infusion pumps during March
2008. No such gain was recorded in the first quarter of 2007.
Interest Income (Expense),
net – Interest expense, net was $5.4 million for the first quarter of
2008 compared to $5.7 million for the first quarter of 2007. Interest
expense for the first quarters of 2008 and 2007 included interest expense of
$4.9 million and $5.6 million, respectively, related to the senior secured term
loan used to finance the Blackstone acquisition. This decrease can be
mainly attributed to less principal as well as a lower interest rate from the
comparable period in the prior year.
Other, net – Other, net was
income of $0.5 million for the first quarter of 2008 compared to expense of $0.6
million for the first quarter of 2007. The increase can be mainly
attributed to the effect of foreign exchange.
Income Tax Expense – Our
estimated worldwide effective tax rates were 46% and 28% during the first
quarters of 2008 and 2007, respectively. The effective tax rate for
the first quarter of 2008 included an unfavorable discrete item resulting from
the sale of operations related to our Pain Care® operations. Excluding this discrete
item, our effective rate was 33%. The effective tax rate for the
first quarter of 2008 was also negatively affected by the expiration of a U.K.
tax planning strategy and the generation of unutilizable net operating losses in
various jurisdictions.
Net Income
– Net income for the first
quarter of 2008 was $3.6 million, or $0.21 per basic and diluted share,
compared to net income of $6.3 million, or $0.38 per basic share and $0.37 per
diluted share, for the first quarter of 2007. The weighted average
number of basic common shares outstanding was 17,087,003 and 16,464,571 during
the first quarters of 2008 and 2007, respectively. The weighted
average number of diluted common shares outstanding was 17,261,172 and
16,926,257 during the first quarters of 2008 and 2007,
respectively.
Liquidity
and Capital Resources
Cash and
cash equivalents at March 31, 2008 were $45.0 million, of which $18.2 million
was subject to certain restrictions under the senior secured credit agreement
described below. This compares to cash and cash equivalents of $41.5
million at December 31, 2007, of which $16.5 million was
restricted.
Net cash
provided by operating activities was $0.9 million for the first three months of
2008 compared to $1.6 million for the first three months of 2007. Net
cash provided by operating activities is comprised of net income, non-cash items
(including share-based compensation and non-cash purchase accounting items from
the Blackstone and Breg acquisitions) and changes in working capital, including
changes in restricted cash. Net income decreased $2.7 million to $3.6
million for the first three months of 2008 from net income of $6.3 million for
the comparable period in the prior year. Non-cash items for the first
quarter of 2008 decreased $0.5 million from the first three months of 2007
primarily as a result of the non-cash effect of an increase in deferred taxes
which was partially offset by the gain on the sale of the operations related to
the Breg Pain Care® line.
Working capital accounts consumed $10.0 million of cash in the first three
months of 2008 compared to $12.4 million in the same period in
2007. The principal uses of cash for working capital can be mainly
attributable to increases in accounts receivable and inventory to support
additional sales and certain operational initiatives which were partially offset
by a decrease in prepaid expenses and other current assets. Overall
performance indicators for our two primary working capital accounts, accounts
receivable and inventory, reflect days sales in receivables of 82 days at March
31, 2008 compared to 84 days at March 31, 2007 and inventory turns of 1.3 times
at March 31, 2008 compared to 1.6 times at March 31, 2007. The lower inventory
turns and resultant higher inventory reflect inventory investment to support
Blackstone sales and support for new internal fixation
products.
Net cash
provided by investing activities was $1.9 million during the first three months
of 2008 compared to $5.6 million used in investing activities during the first
three months of 2007. During the first quarter of 2008, we sold the
operations of our Pain Care® line of
ambulatory infusion pumps for net proceeds of $6.0 million. We also
invested $4.1 million in capital expenditures. During the first three
months of 2007, we invested $4.6 million in capital expenditures of which $2.1
million were related to Blackstone. We also invested $1.0 million in
subsidiaries and affiliates which was a result of adjustments in purchase
accounting related to Blackstone and a purchase of a minority interest in our
subsidiary in Mexico.
Net cash
used in financing activities was $1.2 million in the first quarter of 2008
compared to $0.2 million in the first quarter of 2007. During the
first three months of 2008, we repaid approximately $4.5 million against the
principal on our senior secured term loan and borrowed $1.4 million to support
working capital in our Italian subsidiary. In addition, we received
proceeds of $1.9 million from the issuance of 50,052 shares of our common stock
upon the exercise of stock options and $0.1 million of related tax
benefit. During the first three months of 2007, we repaid $4.8
million against the principal on our senior secured term loan and borrowed $2.6
million to support working capital in our Italian subsidiary. In
addition, we received proceeds of $1.6 million from the issuance of 55,203
shares of our common stock upon the exercise of stock options and $0.4 million
of related tax benefit.
On
September 22, 2006 our wholly-owned U.S. holding company subsidiary, Orthofix
Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured credit
facility with a syndicate of financial institutions to finance the acquisition
of Blackstone. The senior secured credit facility provides for (1) a
seven-year amortizing term loan facility of $330.0 million, the proceeds of
which, together with cash balances were used for payment of the purchase price
of Blackstone; and (2) a six-year revolving credit facility of $45.0
million. As of March 31, 2008 we had no amounts outstanding under the
revolving credit facility and $293.2 million outstanding under the term loan
facility. Obligations under the senior secured credit facility have a
floating interest rate of the London Inter-Bank Offered Rate (“LIBOR”) plus a
margin or prime rate plus a margin. Currently, the term loan is a
LIBOR loan, and the margin is 1.75%, which is adjusted quarterly based upon the
leverage ratio of the Company and its subsidiaries. Our effective
interest rate as of March 31, 2008 on our senior secured credit facility was
4.46%.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) have guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
At March
31, 2008, we had outstanding borrowings of $10.8 million and unused available
lines of credit of approximately 0.4 million Euro ($0.7 million) under a line of
credit established in Italy to finance the working capital of our Italian
operations. The terms of the line of credit give us the option to borrow amounts
in Italy at rates determined at the time of borrowing.
We
continue to search for viable acquisition candidates that would expand our
global presence as well as add additional products appropriate for current
distribution channels. An acquisition of another company or product
line by us could result in our incurrence of additional debt and contingent
liabilities.
We
believe that current cash balances together with projected cash flows from
operating activities, the available revolving credit facility and available
Italian line of credit, the exercise of stock options, and our remaining
available debt capacity are sufficient to cover anticipated working capital and
capital expenditure needs including research and development costs over the near
term.
We are
exposed to certain market risks as part of our ongoing business
operations. Primary exposures include changes in interest rates and
foreign currency fluctuations. These exposures can vary sales, cost of sales,
costs of operations, and the cost of financing and yields on cash and short-term
investments. We use derivative financial instruments, where
appropriate, to manage these risks. However, our risk
management policy does not allow us to hedge positions we do not hold nor do we
enter into derivative or other financial investments for trading or speculative
purposes. As of March 31, 2008, we had a currency swap in place to
minimize foreign currency exchange risk related to a 42.6 million Euro
intercompany note foreign currency exposure.
We are
exposed to interest rate risk in connection with our senior secured term loan
and borrowings under our revolving credit facility, which bear interest at
floating rates based on LIBOR or the prime rate plus an applicable borrowing
margin. Therefore, interest rate changes generally do not affect the fair market
value of the debt, but do impact future earnings and cash flows, assuming other
factors are held constant.
As of
March 31, 2008, we had $293.2 million of variable rate term debt represented by
borrowings under our senior secured term loan at a floating interest rate of
LIBOR plus a margin or the prime rate plus a margin, currently LIBOR plus 1.75%,
which is adjusted quarterly based upon the leverage ratio of the Company and its
subsidiaries. The effective interest rate as of March 31, 2008 on the
senior secured term loan was 4.46%. Based on the balance outstanding
under the senior secured term loan as of March 31, 2008, an immediate
change of one percentage point in the applicable interest rate on the variable
rate debt would cause an increase or decrease in interest expense of
approximately $2.9 million on an annual basis.
Our
foreign currency exposure results from fluctuating currency exchange rates,
primarily the U.S. Dollar against the Euro, Great Britain Pound, Mexican Peso
and Brazilian Real. We face cost of goods currency exposure when we
produce products in foreign currencies such as the Euro or Great Britain Pound
and sell those products in U.S. Dollars. We face transactional
currency exposures when foreign subsidiaries (or the Company itself) enter into
transactions denominated in a currency other than their functional
currency. As of March 31, 2008, we had an uncovered intercompany
receivable denominated in Euro for approximately $11.4 million. We
recorded a foreign currency gain during the first quarter of 2008 of $0.2
million which resulted from the strengthening of the Euro against the U.S.
dollar during the period.
We also
face currency exposure from translating the results of our global operations
into the U.S. dollar at exchange rates that have fluctuated from the beginning
of the period. The U.S. dollar equivalent of international sales
denominated in foreign currencies was favorably impacted during the first
quarters of 2008 and 2007 by foreign currency exchange rate fluctuations with
the weakening of the U.S dollar against the local foreign currency during these
periods. The U.S. dollar equivalent of the related costs denominated
in these foreign currencies was unfavorably impacted during these
periods. As we continue to distribute and manufacture our products in
selected foreign countries, we expect that future sales and costs associated
with our activities in these markets will continue to be denominated in the
applicable foreign currencies, which could cause currency fluctuations to
materially impact our operating results.
Disclosure
Controls and Procedures
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we performed an evaluation of
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Exchange Act Rule 13a - 15(e) or 15d – 15 (e)) as of
the end of the period covered by this report. Based upon that
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that, as of the end of the period covered by this report, our disclosure
controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
In April
2008, we implemented a financial performance management software system (the
“system”) for consolidating and analyzing results for Orthofix International
N.V. The system, developed by COGNOS, is expected to improve and
enhance internal controls over financial reporting. This system
materially changes how financial results are prepared. However, the
implementation has not had a material adverse effect on our internal control
over financial reporting and is not expected to have a material adverse effect
in the future.
Except
for the processes, systems, and controls relating to the conversion to the
system mentioned above, there have not been any changes in our internal control
over financial reporting during the fiscal quarter ended March 31, 2008 that
have materially affected or are reasonably likely to materially affect, our
internal control over financial reporting.
Effective
October 29, 2007, our subsidiary, Blackstone, entered into a settlement
agreement with respect to a patent infringement lawsuit captioned Medtronic
Sofamor Danek USA Inc., Warsaw Orthopedic, Inc., Medtronic Puerto Rico
Operations Co., and Medtronic Sofamor Danek Deggendorf, GmbH v. Blackstone
Medical, Inc., Civil Action No. 06-30165-MAP, filed on September 22, 2006 in the
United States District Court for the District of Massachusetts. In that lawsuit,
the plaintiffs had alleged that (i) they were the exclusive licensees of United
States Patent Nos. 6,926,718 B1, 6,936,050 B2, 6,936,051 B2, 6,398,783 B1 and
7,066,961 B2 (the “Patents”), and (ii) Blackstone's making, selling, offering
for sale, and using within the United States of its Blackstone Anterior Cervical
Plate, 3º Anterior Cervical Plate, Hallmark Anterior Cervical Plate and Construx
Mini PEEK VBR System products infringed the Patents, and that such infringement
was willful. The Complaint requested both damages and an injunction
against further alleged infringement of the Patents. The Complaint did not
specifically state an amount of damages. Blackstone denied
infringement and asserted that the Patents were invalid. On July 20,
2007, we submitted a claim for indemnification from the escrow fund established
in connection with the agreement and plan of merger between the Company, New Era
Medical Corp. and Blackstone, dated as of August 4, 2006 (the “Merger
Agreement”), for any losses to us resulting from this matter. We were
subsequently notified by legal counsel for the former shareholders that the
representative of the former shareholders of Blackstone has objected to the
indemnification claim and intends to contest it in accordance with the terms of
the Merger Agreement. We are unable to predict the outcome of the
escrow claim or to estimate the amount, if any, that may ultimately be returned
to us from the escrow fund. The settlement agreement is not expected
to have a material impact on our consolidated financial position, results of
operations or cash flows.
On or
about July 23, 2007, Blackstone received a subpoena issued by the Department of
Health and Human Services, Office of Inspector General, under the authority of
the federal healthcare anti-kickback and false claims statutes. The
subpoena seeks documents for the period January 1, 2000 through July 31, 2006
which is prior to Blackstone’s acquisition by the Company. We believe
that the subpoena concerns the compensation of physician consultants and related
matters. Blackstone is cooperating with the government’s request and
is in the process of responding to the subpoena. We are unable to
predict what action, if any, might be taken in the future by the Department of
Health and Human Services, Office of Inspector General or other governmental
authorities as a result of this investigation or what impact, if any, the
outcome of this matter might have on our consolidated financial position,
results of operations, or cash flows. On September 17, 2007, we
submitted a claim for indemnification from the escrow fund established in
connection with the Merger Agreement for any losses to us resulting from this
matter. We were subsequently notified by legal counsel for the former
shareholders that the representative of the former shareholders of Blackstone
has objected to the indemnification claim and intends to contest it in
accordance with the terms of the Merger Agreement. We are unable to
predict the outcome of the escrow claim or to estimate the amount, if any, that
may ultimately be returned to us from the escrow fund.
On or
about January 7, 2008, the Company received a federal grand jury subpoena from
the United States Attorney’s Office for the District of
Massachusetts. The subpoena seeks documents for the period January 1,
2000 through July 15, 2007 from us. We believe that the subpoena
concerns the compensation of physician consultants and related matters, and
further believe that it is associated with Department of Health and Human
Services, Office of Inspector General’s investigation of such
matters. We are cooperating with the government’s request and are in
the process of responding to the subpoena. We are unable to predict
what action, if any, might be taken in the future by governmental authorities as
a result of this investigation or what impact, if any, the outcome of this
matter might have on our consolidated financial position, results of operations,
or cash flows. It is our intention to submit a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any recoverable losses to us or Blackstone resulting from this
matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the United States Attorney’s Office for the District of Nevada
(“USAO-Nevada”). The subpoena seeks documents for the period from January 1999
to the present. We believe that the subpoena concerns payments or gifts made by
Blackstone to certain physicians. Blackstone is cooperating with the
government’s request and is in the process of responding to the
subpoena. We are unable to predict what action, if any, might be
taken in the future by the USAO-Nevada or other governmental authorities as a
result of this investigation or what impact, if any, the outcome of this matter
might have on our consolidated financial position, results of operations, or
cash flows. It is our intention to submit a claim for indemnification
from the escrow fund established in connection with the Merger Agreement for any
recoverable losses to us or Blackstone resulting from this
matter.
On
February 29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from
the Massachusetts Attorney General’s Office, Public Protection and Advocacy
Bureau, Healthcare Division. We believe that the CID seeks documents
concerning Blackstone’s financial relationships with certain physicians and
related matters for the period from March 2004 through the date of issuance of
the CID. We are cooperating with the government’s request and are in
the process of responding to the CID. It is our intention to submit a
claim for indemnification from the escrow fund established in connection with
the Merger Agreement for any recoverable losses to us or Blackstone resulting
from this matter.
By order
entered on January 4, 2007, the United States District Court for the Eastern
District of Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et
al., 4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. A qui tam action is
a civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. The complaint
alleges causes of action under the False Claims Act for alleged inappropriate
payments and other items of value conferred on Dr. Chan. On December
29, 2006, the U.S. Department of Justice filed a notice of non-intervention in
the case. Plaintiff subsequently amended the complaint to add
Orthofix International N.V. as a defendant. On January 3, 2008, Dr.
Chan pled guilty to one count of knowingly soliciting and receiving kickbacks
from a medical device distributor in a criminal matter in which neither the
Company nor any of its business units or employees were
defendants. In January 2008, Dr. Chan entered into a settlement
agreement with the plaintiff and certain governmental entities in the civil qui
tam action, and on February 21, 2008, a joint stipulation of dismissal of claims
against Dr. Chan in the action was filed with the court, which removes him as a
defendant in the action. We believe that we have meritorious defenses
to the claims alleged and we intend to defend vigorously against this
lawsuit. On September 17, 2007, we submitted a claim for
indemnification from the escrow fund established in connection with the Merger
Agreement for any losses to us resulting from this matter. We were
subsequently notified by legal counsel for the former shareholders that the
representative of the former shareholders of Blackstone has objected to the
indemnification claim and intends to contest it in accordance with the terms of
the Merger Agreement. We are unable to predict the outcome of the
escrow claim or to estimate the amount, if any, that may ultimately be returned
to us from the escrow fund.
Between
January 2007 and May 2007, Blackstone and Orthofix Inc. were named defendants,
along with other medical device manufacturers, in three civil lawsuits alleging
that Dr. Chan had performed unnecessary surgeries in three different
instances. In January 2008, we learned that Orthofix Inc. was named a
defendant, along with other medical device manufacturers, in a fourth civil
lawsuit alleging that Dr. Chan had performed unnecessary
surgeries. All four civil lawsuits have been served and are pending
in the Circuit Court of White County, Arkansas. We believe that we
have meritorious defenses to the claims alleged and we intends to defend
vigorously against these lawsuits. On September 17, 2007, we
submitted a claim for indemnification from the escrow fund established in
connection with the Merger Agreement for any losses to us resulting from one of
these four civil lawsuits. We were subsequently notified by legal
counsel for the former shareholders that the representative of the former
shareholders of Blackstone has objected to the indemnification claim and intends
to contest it in accordance with the terms of the Merger
Agreement. We are unable to predict the outcome of the escrow claim
or to estimate the amount, if any, that may ultimately be returned to us from
the escrow fund.
In
addition to the foregoing, we have submitted claims for indemnification from the
escrow fund established in connection with the Merger Agreement for losses that
have or may result from certain claims against Blackstone alleging that
plaintiffs and/or claimants were entitled to payments for Blackstone stock
options not reflected in Blackstone's corporate ledger at the time of
Blackstone's acquisition by the Company. To date, the representative
of the former shareholders of Blackstone have not objected to approximately $1.5
million in claims from the escrow fund, with certain claims remaining
pending.
We cannot
predict the outcome of any proceedings or claims made against the Company or its
subsidiaries and there can be no assurance that the ultimate resolution of any
claim will not have a material adverse impact on our consolidated financial
position, results of operations, or cash flows.
In
addition to the foregoing, in the normal course of our business, the Company is
involved in various lawsuits from time to time and may be subject to certain
other contingencies.
There
have been no material changes to our risk factors from the factors discussed in
Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2007.
Exhibit
Number
|
Description
|
|
|
3.1
|
Certificate
of Incorporation of the Company (filed as an exhibit to the Company’s
annual report on Form 20-F dated June 29, 2001 and incorporated herein by
reference).
|
|
|
3.2
|
Articles
of Association of the Company as amended (filed as an exhibit to the
Company’s quarterly report on Form 10-Q for the quarter ended June 30,
2007 and incorporated herein by reference).
|
|
|
10.1
|
Orthofix
Inc. Employee Stock Purchase Plan (filed as an exhibit to the Company’s
annual report on Form 10-K for the fiscal year ended December 31, 2002 and
incorporated herein by reference).
|
|
|
10.2
|
Orthofix
International N.V. Staff Share Option Plan, as amended through April 22,
2003 (filed as an exhibit to the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2007 and incorporated herein by
reference).
|
|
|
10.3
|
Orthofix
International N.V. Amended and Restated 2004 Long Term Incentive Plan
(filed as an exhibit to the Company’s current report on Form 8-K filed
June 26, 2007 and incorporated herein by reference).
|
|
|
10.4
|
Form
of Nonqualified Stock Option Agreement Under the Orthofix International
N.V. Amended and Restated 2004 Long Term Incentive Plan (filed as an
exhibit to the Company’s registration statement on Form S-8 filed August
23, 2007 and incorporated herein by reference).
|
|
|
10.5
|
Form
of Restricted Stock Grant Agreement under the Orthofix International N.V.
Amended and Restated 2004 Long-Term Incentive Plan (filed as an exhibit to
the Company’s quarterly report on Form 10-Q for the quarter ended June 30,
2007 and incorporated herein by reference).
|
|
|
10.6
|
Orthofix
Deferred Compensation Plan (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2006, as
amended, and incorporated herein by reference).
|
|
|
10.7
|
Employment
Agreement, dated as of April 15, 2005, between the Company and Charles W.
Federico (filed as an exhibit to the Company’s current report on Form 8-K
filed April 18, 2005 and incorporated herein by
reference).
|
10.8
|
Amended
and Restated Employment Agreement, dated as of December 7 2007, between
Orthofix Inc. and Thomas Hein (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
|
|
|
10.9
|
Employment
Agreement, dated as of November 20, 2003, between Orthofix International
N.V. and Bradley R. Mason (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2003 and
incorporated herein by reference).
|
|
|
10.10
|
Acquisition
Agreement dated as of November 20, 2003, among Orthofix International
N.V., Trevor Acquisition, Inc., Breg, Inc. and Bradley R. Mason, as
shareholders’ representative (filed as an exhibit to the Company’s current
report on Form 8-K filed January 8, 2004 and incorporated herein by
reference).
|
|
|
10.11
|
Amended
and Restated Voting and Subscription Agreement dated as of December 22,
2003, among Orthofix International N.V. and the significant shareholders
of Breg, Inc. identified on the signature pages thereto (filed as an
exhibit to the Company’s current report on Form 8-K filed on January 8,
2004 and incorporated herein by reference).
|
|
|
10.12
|
Amendment
to Employment Agreement dated December 29, 2005 between Orthofix Inc. and
Charles W. Federico (filed as an exhibit to the Company’s current report
on Form 8-K filed December 30, 2005 and incorporated herein by
reference).
|
|
|
10.13
|
Form
of Indemnity Agreement (filed as an exhibit to the Company’s annual report
on Form 10-K filed December 31, 2005 and incorporated herein by
reference).
|
|
|
10.14
|
Settlement
Agreement dated February 23, 2006, between Intavent Orthofix Limited, a
wholly-owed subsidiary of Orthofix International N.V. and Galvin Mould
(filed as an exhibit to the Company’s annual report on Form 8-K filed on
April 17, 2006 and incorporated herein by reference).
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|
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10.15
|
Amended
and Restated Employment Agreement, dated December 6, 2007, between
Orthofix Inc. and Alan W. Milinazzo (filed as an exhibit to the Company’s
annual report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
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|
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10.16
|
Amended
and Restated Employment Agreement, dated December 6, 2007,
between Orthofix Inc. and Raymond C. Kolls (filed as an exhibit to the
Company’s annual report on Form 10-K for the fiscal year ended December
31, 2007, as amended, and incorporated herein by
reference).
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|
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10.17
|
Amended
and Restated Employment Agreement, dated December 6, 2007, between
Orthofix Inc. and Michael M. Finegan. (filed as an exhibit to the
Company’s annual report on Form 10-K for the fiscal year ended December
31, 2007, as amended, and incorporated herein by
reference).
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|
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10.18
|
Credit
Agreement, dated as of September 22, 2006, among Orthofix Holdings, Inc.,
Orthofix International N.V., certain domestic subsidiaries of Orthofix
International N.V., Colgate Medical Limited, Victory Medical Limited,
Swiftsure Medical Limited, Orthofix UK Ltd, the several banks and other
financial institutions as may from time to time become parties thereunder,
and Wachovia Bank, National Association (filed as an exhibit to the
Company’s current report on Form 8-K filed September 27, 2006 and
incorporated herein by reference).
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10.19
|
Agreement
and Plan of Merger, dated as of August 4, 2006, among Orthofix
International N.V., Orthofix Holdings, Inc., New Era Medical Limited,
Blackstone Medical, Inc. and William G. Lyons, III, as Equityholders’
Representative (filed as an exhibit to the Company's current report on
Form 8-K filed August 7, 2006 and incorporated herein by
reference).
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10.20
|
Employment
Agreement, dated as of September 22, 2006, between Blackstone Medical,
Inc. and Matthew V. Lyons (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2006, as
amended, and incorporated herein by reference).
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|
|
10.21
|
Description
of Orthofix International N.V.’s Annual Incentive Plan including the Form
of Participation Letter (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2006, as
amended, an incorporated herein by reference).
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|
|
10.22
|
Amended
and Restated Employment Agreement dated December 6, 2007 between Orthofix
Inc. and Timothy M. Adams (filed as an exhibit to the Company’s annual
report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
|
|
|
10.23
|
Letter
Agreement between Orthofix International N.V. and Bradley R. Mason dated
November 20, 2007 (filed as an exhibit to the Company’s current report on
Form 8-K filed November 21, 2007 and incorporated herein by
reference).
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|
|
10.24
|
Amended
and Restated Performance Accelerated Stock Option Agreement between
Orthofix International N.V. and Bradley R. Mason dated November 20, 2007
(filed as an exhibit to the Company’s annual report on Form 10-K for the
fiscal year ended December 31, 2007, as amended, and incorporated herein
by reference).
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|
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10.25
|
Nonqualified
Stock Option Agreement between Timothy M. Adams and Orthofix International
N.V. dated November 19, 2007 (filed as an exhibit to the Company’s current
report on Form 8-K filed November 21, 2007 and incorporated herein by
reference).
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|
|
10.26
|
Letter
Agreement between Orthofix Inc. and Thomas Hein dated December 6, 2007
(filed as an exhibit to the Company’s current report on Form 8-K filed
December 11, 2007 and incorporated herein by
reference).
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|
|
10.27
|
First
Amendment to Orthofix Inc. Employee Stock Purchase Plan, dated as of
December 11, 2007 (filed as an exhibit to the Company’s annual report on
Form 10-K for the fiscal year ended December 31, 2007, as amended, and
incorporated herein by reference).
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|
|
10.28
|
Employment
Agreement between Orthofix Inc. and Oliver Burckhardt, dated as of
December 11, 2007 (filed as an exhibit to the Company’s annual report on
Form 10-K for the fiscal year ended December 31, 2007, as amended, and
incorporated herein by reference).
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|
|
10.29
|
Employment
Agreement between Orthofix Inc. and Scott Dodson, dated as of December 10,
2007 (filed as an exhibit to the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2007, as amended, and incorporated
herein by reference).
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|
|
10.30
|
Employment
Agreement between Orthofix Inc. and Michael Simpson, dated as of December
6, 2007 (filed as an exhibit to the Company’s annual report on Form 10-K
for the fiscal year ended December 31, 2007, as amended, and incorporated
herein by reference).
|
|
|
10.31
|
Description
of Director Fee Policy (filed as an exhibit to the Company’s annual report
on Form 10-K for the fiscal year ended December 31, 2007, as amended, and
incorporated herein by
reference).
|
10.32
|
Summary
of Orthofix International N.V. Annual Incentive Program (filed as an
exhibit to the Company’s current report on Form 8-K filed April 11, 2008,
and incorporated herein by reference).
|
|
|
|
Employment
Agreement between Orthofix Inc. and Thomas Hein dated as of April 11,
2008.
|
|
|
|
Nonqualified
Stock Option Agreement under the Orthofix International N.V. Amended and
Restated 2004 Long-Term Incentive Plan, dated April 11, 2008, between
Orthofix International N.V. and Thomas Hein.
|
|
|
|
Summary
of Consulting Arrangement between Orthofix International N.V. and
Peter Hewett.
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive
Officer.
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial
Officer.
|
|
|
|
Section
1350 Certification of Chief Executive Officer.
|
|
|
|
Section
1350 Certification of Chief Financial
Officer.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
ORTHOFIX
INTERNATIONAL N.V.
|
|
|
|
|
|
|
Date: May
7, 2008
|
By:
|
/s/ Alan W.
Milinazzo
|
|
|
Name: Alan
W. Milinazzo
|
|
|
Title: Chief
Executive Officer and President
|
|
|
|
Date: May
7, 2008
|
By:
|
/s/ Thomas
Hein
|
|
|
Name: Thomas
Hein
|
|
|
Title: Chief
Financial Officer
|
33